BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX EXTENDER

    MDR report key: 20334026 · Received September 30, 2024

    Report

    Report Number
    2028807-2024-00034
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Report Date
    November 7, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    CAI
    UDI-DI
    10709078008402
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 0004292717 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 30 SEP 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT: 0004292717 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. A REPRESENTATIVE SAMPLE WAS RETURNED BY THE CUSTOMER FOR EVALUATION, DURING SET UP, TWO OF THE CONNECTORS FELL OUT; DURING TESTING THE CONNECTION FORCE WAS FOUND TO BE BELOW SPECIFICATION. IN ADDITION TO TESTING, THE DRAWINGS WERE INSPECTED AND IT WAS DETERMINED THE CONNECTOR, ON THE RETURNED PRODUCT, DID NOT HAVE THE RETAINING RING, WHICH RESULTED IN A POOR CONNECTION FORCE BETWEEN THE CONNECTORS AND THE FLEX TUBE. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED; THE ROOT CAUSE WAS TRACED TO THE MANUFACTURING PROCESS. ALL INFORMATION REASONABLY KNOWN AS OF 07 NOV 2024, HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT: (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00053 FOR THE SECOND REPORT REFER TO 2028807-2024-00054 FOR THE THIRD REPORT. IT WAS REPORTED, THE FLEX CONNECTOR SEPARATED FROM THE BREATHING CIRCUIT, AS IT HEATED, IN THE MIDDLE OF THE CASE; THEY HAD TO FIND THE CONNECTION ISSUE DURING THE CASE AND REATTACH IT. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00053 FOR THE SECOND REPORT. REFER TO 2028807-2024-00054 FOR THE THIRD REPORT. IT WAS REPORTED, THE FLEX CONNECTOR SEPARATED FROM THE BREATHING CIRCUIT, AS IT HEATED, IN THE MIDDLE OF THE CASE; THEY HAD TO FIND THE CONNECTION ISSUE DURING THE CASE AND REATTACH IT. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962716 FLEX EXTENDER FLEX EXTENDER, 5.2 CAI WESTMED LLC 7-5132 0004292717 10709078008402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown